{"id":"romosozumab-prefilled-syringe","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Back pain"},{"rate":"10-20%","effect":"Headache"},{"rate":"10-20%","effect":"Musculoskeletal pain"}]},"_chembl":{"chemblId":"CHEMBL2107874","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By binding to sclerostin, romosozumab increases the production of osteoblasts, which are cells responsible for bone formation. This leads to an increase in bone mass and a decrease in bone resorption, making it a potential treatment for osteoporosis and other bone-related disorders.","oneSentence":"Romosozumab Prefilled Syringe is a monoclonal antibody that targets sclerostin to increase bone formation and decrease bone resorption.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:32:36.985Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of osteoporosis in postmenopausal women at high risk of fracture"}]},"trialDetails":[{"nctId":"NCT04800367","phase":"PHASE2","title":"Romosozumab/Denosumab Study for Premenopausal IOP","status":"ACTIVE_NOT_RECRUITING","sponsor":"Columbia University","startDate":"2021-03-12","conditions":"Premenopausal Idiopathic Osteoporosis","enrollment":30},{"nctId":"NCT05775094","phase":"PHASE1","title":"A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2023-03-07","conditions":"Osteoporosis, Multiple Myeloma","enrollment":10},{"nctId":"NCT04779216","phase":"PHASE3","title":"Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa","status":"COMPLETED","sponsor":"Karen Klahr Miller, MD","startDate":"2021-09-20","conditions":"Bone Density, Low, Bone Loss, Anorexia Nervosa","enrollment":30},{"nctId":"NCT06079476","phase":"PHASE4","title":"A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.","status":"COMPLETED","sponsor":"Amgen","startDate":"2023-10-30","conditions":"Postmenopausal Osteoporosis","enrollment":100},{"nctId":"NCT06720350","phase":"PHASE4","title":"Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures","status":"NOT_YET_RECRUITING","sponsor":"Marmara University","startDate":"2025-01-15","conditions":"Osteoporosis in Post-menopausal Women","enrollment":60},{"nctId":"NCT01833754","phase":"PHASE1","title":"Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis","status":"COMPLETED","sponsor":"Amgen","startDate":"2013-04-22","conditions":"Osteoporosis","enrollment":24},{"nctId":"NCT03432533","phase":"PHASE3","title":"A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2018-02-06","conditions":"Post-Menopausal Osteoporosis","enrollment":283},{"nctId":"NCT02016716","phase":"PHASE3","title":"A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2013-12-03","conditions":"Postmenopausal Osteoporosis","enrollment":294}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Romosozumab Prefilled Syringe","genericName":"Romosozumab Prefilled Syringe","companyName":"Karen Klahr Miller, MD","companyId":"karen-klahr-miller-md","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Romosozumab Prefilled Syringe is a monoclonal antibody that targets sclerostin to increase bone formation and decrease bone resorption. Used for Treatment of osteoporosis in postmenopausal women at high risk of fracture.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}